Kornimate/medical-research-clean huggingface dataset:
study to evaluate two diagnostic strategies for the treatment of severe community acquired pneumonia (scap)

Conditions: Community Aquired Pneumonia

Summary: main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be performed by non invasive or semi invasive microbiological tools, semi invasive tools including protected distal bronchial samplings by the mean of fiber optic bronchoscopy (fob). a microbiological diagnosis could improve antibiotic therapy efficacy and improve patient's outcome. these two strategies have never been prospectivally evauated. * aim of the study: to evaluate 2 diagnostic strategies: non invasive or semi invasive including protected distal bronchial samplings by the mean of fiber optic bronchoscopy (fob)for the care of patients admitted in intensive care for severe community acquired pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 american thoracic guidelines * type of study randomized multicentric controlled open study

type of study randomized multicentric controlled open study number of patients: 200 patients (100 patients in each group)admitted in icu for scap * number of center : 5 * clinical strategies under evaluation : * group a: semi-invasive strategy: fob within 24 hours after icu admission * group b: non-invasive strategy: no fob within 24 hours after icu admission * evaluation criteria: main criteria: changes in initial empirical antibiotic treatment according to microbiological results obtained in each group. others * fob related complications * microbiological results * type of antibiotic treatment modifications * icu outcome and outcome at day 28 * duration of antibiotic therapy and nimber of days without antibiotics at day 28 after inclusion

Eligibility criteria:
inclusion criteria: new radiological infiltrate scap clinical diagnosis admitted in icu admitted in hospital for less than 24 hours aged 18 or older signed informed consent exclusion criteria: pregnancy muribond patients previuos hospitalisation within one month neutropenia none hiv status
assessment of supersonic imagine aixplorer for the detection and localisation of prostate cancer foci

Conditions: Cancer of Prostate

Summary: the primary aim of the study is to assess the elasticity (young's modulus) of cancerous tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. images obtained with the supersonic imagine aixplorer scanner prior to radical prostatectomy are compared to whole-mount histology.


Eligibility criteria:
inclusion criteria: * patient over 18 years old, with prostate cancer and scheduled for radical prostatectomy exclusion criteria: * medical history of prostate surgery or radiotherapy of prostate * medical history of abdominal perinéanal amputation or whole of state which prevent to use endorectal probe

Keywords: prostate cancer elastography elasticity
effect of zoledronic acid in patients with prostate cancer and bone metastasis

Conditions: Prostate Cancer Patients With Bone Metastasis

Summary: it is the aim of this clinical study to evaluate the skeletal-related event rate and tolerability of zoledronic acid in patients with prostate cancer patients and bone metastases.


Eligibility criteria:
inclusion criteria: * signed informed consent * a histologically confirmed diagnosis of carcinoma of the prostate * therapy with hormonal treatments (medical or surgical castration) * patients must have objective evidence of metastatic disease to bone. * adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value * ecog performance status of 0, 1 or 2 exclusion criteria: * bone pain which requires strong narcotic therapy with centrally acting analgesic agents. * more than 3 bisphosphonate applications in patients history. * previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 3 months prior to visit 2. * abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute. creatinine clearance (crcl) is calculated using the cockcroft-gault formula: crcl= \[140-age (years)\] x weight (kg) {x 0.85 for female patients} \[72 x serum creatinine (mg/dl)\] * corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l) or ≥ 12.0 mg/dl (3.00 mmol/l) * life expectancy \< 6 months * patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment * use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization * current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures. * recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) other protocol-defined inclusion and exclusion criteria may apply.

Keywords: prostate cancer bone metastasis skeletal related event
severe aortic valve stenosis and concomitant coronary artery disease in patients undergoing tavi

Conditions: Aortic Valve Stenosis; Coronary Artery Disease

Summary: patients undergoing surgical aortic valve replacement (savr) with concomitant coronary artery disease (cad) are known to have higher mortality rates compared to patients without cad. this same phenomenom has not been clearly mapped in patients with cad that goes through a transcatheter aortic valve implantation procedure.

a narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. when the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. since the 60's, surgical aortic valve replacement (savr) has been the treatment of choice for severe aortic stenosis. a large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk. transcatheter aortic valve implantation (tavi) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. the procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. patients with an underlying coronary artery disease (cad) undergoing savr is known to have higher mortality rates postoperatively. however, it is not clearly known how an underlying cad affects the long term results after a tavi-surgery. it is therefore our goal to contribute with the mapping of how a cad affects the long term results for patients with a severe aortic valve stenosis that undergoes tavi.

Eligibility criteria:
inclusion criteria: * all patients that underwent a tavi procedure at örebro university hospital between 2009 till 1st december 2019. exclusion criteria: * patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.

Keywords: aortic valve stenosis coronary artery disease transcatheter aortic valve implantation mortality
phase ii study with rituximab and cyclophosphamide, doxorubicin, vincristine, prednisone (chop) in patients with gastric diffuse large b-cell non-hodgkin's lymphoma

Conditions: Primary Gastric Diffuse-Large B-Cell Lymphoma

Summary: the optimal treatment of primary gastric diffuse large b-cell lymphoma (pg-dlbcl) has not yet been defined. in most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. recently, rituximab along with full-dose chop chemotherapy has been shown to improve the outcome in elderly patients with nodal dlbcl. however, no data are available with such a therapy in patients with pg-dlbcl. therefore, in march 2003, we initiated an ongoing, prospective, multicenter phase ii study in patients with pg-dlbcl with 6 to 8 cycles of rituximab (r; 375 mg/m2) plus chop-21 in order to evaluate the safety and efficacy of this approach.

see above

Eligibility criteria:
inclusion criteria: * age \> 18 years * histologically confirmed primary gastric cd20+ dlbcl * written informed consent * ecog 0-2 exclusion criteria: * secondary aggressive non-hodgkin's lymphoma involving the gastric area * hiv positive patients * severe organ dysfunction * life expectancy of less than 3 months

Keywords: rituximab chop dlbcl gastric lymphoma
autologous bone marrow derived stem cells for the treatment of multiple sclerosis.

Conditions: Multiple Sclerosis

Summary: until now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. we propose the use of autologous bone marrow-derived specific stem cell populations and mesenchymal stem cell transplantation (bm-msc) associated with immuno-modulation to treat patients with relapsing-remitting ms (rrms).

multiple sclerosis (ms) is an autoimmune de-myelinating disease in which the myelin sheaths of nerve cells in the central nervous system are damaged.this damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and psychiatric issues. to date, there is no known cure for multiple sclerosis. treatments attempt to improve function after an attack and prevent new attacks. stem cells possess strong immunomodulatory properties that are shown to play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and that may stimulate repair and regeneration of lesion. clinical studies have shown that stem cells can be safely harvested and do not form tumors. most of human stem cell trials have focused on clinical applications for haematopoietic stem cells (hsc), mesenchymal stem cells (msc), or both. when administered intravenously they have an immune inhibitory effect that can ameliorate animal autoimmune diseases. msc transplantation significantly improves clinical outcome in experimental allergic encephalitis (eae). when administered intravenously, msc may migrate to inflammatory brain lesions and promote survival of nervous cells. hence, msc have become the focus of studies as a potential cell therapy for stimulating neuro-protection in human neurodegenerative diseases such as ms. we propose a safety and efficacy trial of a intravenous and intrathecal injections of autologous bone marrow-derived stem cells into patients with ms.

Eligibility criteria:
inclusion criteria: * relapsing-remitting ms (rrms) patients * age 18-50 years * disease duration \>= 2 and \<= 10 years * edss: 3.0 - 6.5 exclusion criteria: * rrms not fulfilling inclusion criteria * spms or ppmstreatment with any immunosuppressive therapy * treatment with interferon-beta or glatiramer acetate within the 30 days prior to transplantation * treatment with corticosteroids within the 30 days prior to transplantation * relapse occurred during the 60 days prior to transplantation * history of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for hiv, hepatitis b or c * pregnancy or risk of pregnancy/ lactation * current treatment with an investigational therapy * inability to give written informed consent in accordance with research ethics board guidelines
aveir ar coverage with evidence development (ced) study

Conditions: Cardiac Pacemaker; Arrhythmia; Bradycardia

Summary: the purpose of this coverage with evidence development (ced) study is to evaluate complications and long-term health outcomes of the single-chamber aveir atrial leadless pacemaker device (aka aveir™ ar lp system).

this ced study utilizes a real-world evidence (rwe) method merging multiple real-world datasets from abbott and the center for medicare services to assess aveir ar lp health outcomes among medicare beneficiaries. the study will enroll all medicare patients with continuous claims data implanted with the aveir ar lp or a single-chamber atrial transvenous pacemaker system from any manufacturer. due to the rwe data collection methods used in this study, a central institutional review board (irb) approved informed consent waiver has been granted. due to this waiver and the sponsor's use of the central irb, individual hospitals are not required to consent patients or complete local irb submissions for this rwe study.

Eligibility criteria:
inclusion criteria: 1. medicare beneficiaries implanted with an aveir ar leadless pacemaker on or after the study start date (i.e., the date of aveir ar market approval) will be included in the study. or 2. medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date exclusion criteria: * none
thrombin generation and gestational outcome

Conditions: Thrombophilia

Summary: in total 120 pregnant women's with history of recurrent miscarriages, are planned for inclusion in this trial. after signing an informed consent a blood sample will be obtained from each participant. the investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (cat). the relation between pregnancy outcome and thrombin measurements will be determined


Eligibility criteria:
inclusion criteria: * age \> 18 * signed inform consent * first trimester * two early miscarriages(before week 10) or one later abortions (after week 10) exclusion criteria: * chronic treatment with aspirin or other anticoagulants
intensive dysarthria sessions in adults and children with down syndrome

Conditions: Dysarthria; Down Syndrome

Summary: this research study is designed to investigate the feasibility and treatment effects of a behavioral speech treatment in adults and children with down syndrome (ds) and dysarthria. the speech sessions will provide an intensive, articulation-based intervention focused on increasing effort during speech production via use of "clear speech." a single subject multiple baselines across subjects design will be employed in a total of six subjects divided into two groups of three. changes in dependent measures will be determined by visual inspection, effect size determination, and time series analysis. the study follows accepted procedures in rehabilitation treatment and research and there are minimal foreseeable risks associated with participation.


Eligibility criteria:
inclusion criteria: * adults and children with downs syndrome and dysarthria * ages 8 years and older * ability to verbally communicate; follow simple commands and/or imitate others; hear speech at a conversational level; and participate in assessment and speech sessions activities exclusion criteria: * additional serious medical problems which prevent meaningful participation in the study.
risk factors and prediction score of ards after cardiac surgery

Conditions: Respiratory Distress Syndrome, Adult; Thoracic Surgery; Risk Factors

Summary: acute respiratory distress syndrome following cardiac surgery severely affects the prognosis of patients; the mortality is up to 40%. although experience many years of research and exploration, the effective methods for the treatment of acute respiratory distress syndrome is still relatively limited at present, including lung protective mechanical ventilation respiratory support, fluid management, glucocorticoid and other integrated organ function maintenance measures. it is currently the research of acute respiratory distress syndrome aims at the early discovery and takes effective measures to prevent its occurrence, hoping to improve the prognosis of patients. according to risk factors is established through the analysis of lung injury score early warning system, the early identification of acute respiratory distress syndrome patients at high risk, before the occurrence of acute respiratory distress syndrome take corresponding preventive measures can effectively reduce the incidence rate and mortality. so far, domestic and foreign research on the establishment of acute respiratory distress syndrome scoring early warning system is less. cardiac surgery has significant characteristics, type of operation, location, operation, intraoperative blood transfusion and oxygenation, postoperative factors, are likely to be the factors of acute respiratory distress syndrome. as far as investigators know, so far there are few specialized for acute respiratory distress syndrome predicting lung injury after cardiac surgery. this study will be completed after the implementation of individualized dynamic lung injury score evaluation of cardiac surgery patients, identification of high-risk acute respiratory distress syndrome patients, to assist clinicians in early decision, take preventive measures. this study will improve the prognosis of acute respiratory distress syndrome patients after cardiac surgery; it is of great significance to improve the level of intensive care after cardiac surgery.


Eligibility criteria:
inclusion criteria: * retrospective group: cardiac surgery patients accepted from jan 2013 to dec 2015 * prospective group: cardiac surgery patients accepted from 2017 january to december exclusion criteria: * refused to participate in the study * age less than 18 years old * before operation performed mechanical ventilation * before operation underwent iabp treatment * before operation continuous renal replacement therapy * before operation undergoing in vitro membrane oxygenator treatment * before operation has the pulmonary imaging showed bilateral pulmonary diffuse exudation of interstitial pneumonia, pulmonary infection or respiratory failure * the major trauma, sepsis, aspiration, shock, acute heart failure * before operation diagnosed as malignant tumor * incomplete data.
icotinib and arsenic trioxide in treating non-small-cell lung cancer patients with resistance to egfr-tki

Conditions: Non-small Cell Lung Cancer

Summary: the nsclc patients who experienced good clinical responses to an egfr-tki will inevitably develop acquired resistance. a great deal of research are focusing on this issue. arsenic trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and other solid tumors. moreover, preclinical studies showed arsenic trioxide can reduce the resistance of tumor cells to chemotherapy and tkis.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib/iv lung cancer with egfr mutation * progressed after platinum-based chemotherapy * the last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months * with a measurable disease with conventional ct) according to recist criteria * who performance status(ps)\<= 2 * n\>=1.5×109/l, plt\>=1.0×109/l,hb\>=9g/dl; ast\&alt should \<2.5uln(without liver metastasis) or \<5uln(with liver metastasis).tbil\<=1.5uln. * signed and dated informed consent before the start of specific protocol procedures. exclusion criteria: * allergic to icotinib or arsenic trioxide. * patients with metastatic brain tumors with symptoms. * severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Keywords: icotinib arsenic trioxide resistance non-small cell lung cancer
retrospective study to review patients at risk for vte at hospital discharge

Conditions: Venous Thromboembolism

Summary: an investigator initiated study exploring vte prophylaxis at the time of hospital discharge.

it appears likely that many patients will remain at risk for vte at the time of hospital discharge. these risks will go unrecognized, and discharge prophylaxis orders will not be prescribed. to test this hypothesis, we will perform a retrospective review of approximately 2,500 patients at brigham and women's hospital at risk for vte at the time of hospital discharge to determine what proportion received vte prophylaxis. we will correlate the implementation of discharge vte prophylaxis with the occurrence of symptomatic dvt and pulmonary embolism within 90 days of hospital discharge. we will also conduct a substudy of this patient population to determine adherence to vte prophylaxis among hospitalized patients.

Eligibility criteria:
inclusion criteria: * acutely ill medical and surgical patients with a risk score of 4 or greater without prophylaxis or a risk score of 4 or greater with anticoagulation at hospital discharge. exclusion criteria: * none.
correlation between respiratory impairment and phonemes alteration in dystrophinopathy patients with respiratory failure

Conditions: During the Medical Appointment, the Speech Therapist Will Perform Phonetic Tests

Summary: communication is essential for patients quality of life because it impact on patients care quality. neuromuscular diseases, caracterised by motor damages, hinder non-verbal communication of the patient. therefore, speech must to be functional. however, correlation between respiratory failure and voice quality is not very well known. the aim of the study is to search a link between respiratory failure and speech impairment in patients with neuromuscular diseases.


Eligibility criteria:
inclusion criteria: * respiratory autonomy at least 1 hour per day * stable patient during the study * patient with education at least up to secondary school exclusion criteria: * refusal to participate * inability to cooperate * tracheostomized patients * mechanic ventilation - dependant patients * respiratory autonomy lower than 1 hour per day * patients with hemodynamic instabillity * patient insured under the french social security system
the effectiveness of a pediatric lumbar puncture restraint device

Conditions: Indication for Lumbar Puncture

Summary: this is a pilot study to evaluate a restraint device for lumbar punctures. designed to help improve the restraint techniques for lumbar puncture, the restraint device will be compared to the current standard of manual physical restraint in neonatal and pediatric patients (age 1 day to 90 days of life). the investigators will study 30 subjects, with 20 randomized for the experimental device and 10 randomized for the "control" group, which is current standard of care. the investigators' primary outcomes will include time of procedure, red blood cells in the cerebrospinal fluid as well as physician satisfaction. subjects will be eligible if they are 1-90 days of life, and their treating physician believes lumbar puncture is indicated. there is no follow-up once the lumbar puncture has been completed and the data has been obtained.


Eligibility criteria:
inclusion criteria: * age 1 to 90 days of life * indication for lumbar puncture procedure as determined by the treating physician * informed consent from the subject's legal guardian indicating their acceptance of a lumbar puncture for the work-up of sepsis * informed consent to enrolled in said protocol exclusion criteria: * no indication for lumbar puncture procedure as determined by treating physician

Keywords: lumbar puncture positioning device